A Study of Subcutaneous RoActemra/Actemra (Tocilizumab) as Monotherapy or in Combination With Methotrexate or Other Non-Biologic DMARDs in Patients With Active Rheumatoid Arthritis

Last updated: June 20, 2017
Sponsor: Hoffmann-La Roche
Overall Status: Completed

Phase

3

Condition

Rheumatoid Arthritis

Joint Injuries

Arthritis And Arthritic Pain

Treatment

N/A

Clinical Study ID

NCT01995201
ML28709
2013-002429-52
  • Ages > 18
  • All Genders

Study Summary

This multicenter, open-label study will evaluate the efficacy and safety of subcutaneously administered RoActemra/Actemra (tocilizumab) as monotherapy or in combination with methotrexate or other non-biologic DMARDs in patients with active rheumatoid arthritis and an inadequate response to non-biologic DMARDs or to one anti-TNF. In Phase 1, all patients will receive RoActemra/Actemra 162 mg subcutaneously (sc) weekly for Weeks 1 to 24, with or without methotrexate or other non-biologic DMARDs. For Part 2, patients who achieve sustained clinical DAS28-ESR remission at Weeks 20 and 24 will be randomized to receive RoActemra/Actemra 162 mg sc either weekly or every 2 weeks for Weeks 24 to 48, with or without methotrexate or other non-biologic DMARDs. Patients who do not achieve sustained clinical remission but achieve low disease activity (DAS-ESR </= 3.2) will continue the initial treatment of RoActemra/Actemra 162 mg sc weekly for Weeks 24 to 48, with or without methotrexate or other non-biologic DMARDs.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients, >/= 18 years of age

  • Active rheumatoid arthritis (DAS28-ESR > 3.2), according to the revised (1987) ACRcriteria or EULAR/ACR (2010) criteria of > 6 months duration

  • Patients with intolerance or inadequate response to methotrexate or other non-biologicDMRADs or inadequate response to a first ant-TNF agent

  • Oral corticosteroids (</= 10 mg/day prednisone or equivalent) and non-steroidalanti-inflammatory drugs (NSAIDs; up to the maximum recommended dose) are permitted ifon a stable dose regimen for >/= 4 weeks prior to baseline

  • Permitted non-biologic DMRAD is allowed if at stable dose for at least 4 weeks priorto baseline

  • Females of childbearing potential and males with female partners of childbearingpotential must be using a reliable means of contraception as defined by protocolduring the study and for at least 3 months following the last dose ofRoActemra/Actemra

  • Patients with intolerance or inadequate response to methotrexate or other non-biologicDMARDs or inadequate response to first anti-TNF agent

Exclusion

Exclusion Criteria:

  • Major surgery (including joint surgery) within 8 weeks prior to screening or plannedmajor surgery within 6 months following baseline

  • Rheumatic autoimmune disease other than RA or significant systemic involvementsecondary to RA; secondary Sjögren's syndrome with RA is permitted

  • Functional Class IV as defined by the ACR Classification of Functional Status inRheumatoid Arthritis

  • Diagnosis of juvenile idiopathic arthritis or juvenile RA and/or RA before the age of 16

  • Prior history of current inflammatory joint disease other than RA

  • Exposure to tocilizumab (either intravenous [IV] or SC) at any time prior to baseline

  • Treatment with any investigational agent with four weeks (or five-half lives of theinvestigational drug, whichever is longer) of screening

  • Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline

  • Previous treatment with Abatacept

  • History of severe allergic of anaphylactic reactions to human, humanized, or murinemonoclonal antibodies

  • Evidence of serious uncontrolled concomitant cardiovascular, nervous system,pulmonary, renal, hepatic, endocrine, or gastrointestinal (GI) disease

  • History of diverticulitis, diverticulitis requiring antibiotic treatment, or chroniculcerative lower GI disease such as Crohn's disease, ulcerative colitis, or othersymptomatic lower GI conditions that might predispose to perforation

  • Known active current or history of recurrent bacterial, viral, fungal, mycobacterial,or other infections (including but not limited to tuberculosis [TB] and atypicalmycobacterial disease, hepatitis B and C, and herpes zoster, but excluding fungalinfections or nail beds)

  • Any major episode of infection requiring hospitalization or treatment with IVantibiotics within 4 weeks of screening or oral antibiotics within 2 weeks ofscreening

  • Active TB requiring treatment within the previous 3 years

  • Positive hepatitis B or hepatitis C

  • Primary or secondary immunodeficiency (history of or currently active)

  • Evidence of active malignant disease, malignancies diagnosed with the previous 10years (including hematological malignancies and solid tumors, except basal of squamouscell carcinoma of the skin diagnosed within the previous 20 years

  • Pregnant and lactating women

  • History of alcohol, drug, or chemical abuse within 1 year prior to screening

  • Neuropathies or other conditions that might interfere with pain evaluation

  • Inadequate hematological, real of liver function

Study Design

Total Participants: 401
Study Start date:
September 01, 2013
Estimated Completion Date:
March 31, 2016

Connect with a study center

  • Co Leitrim,
    Ireland

    Site Not Available

  • Cork,
    Ireland

    Site Not Available

  • Dublin, 24
    Ireland

    Site Not Available

  • Dublin 4, 4
    Ireland

    Site Not Available

  • Limerick, 0
    Ireland

    Site Not Available

  • Waterford,
    Ireland

    Site Not Available

  • Almada, 2801-951
    Portugal

    Site Not Available

  • Amadora, 3814-501
    Portugal

    Site Not Available

  • Lisboa, 1649-035
    Portugal

    Site Not Available

  • Porto, 4200-319
    Portugal

    Site Not Available

  • Elche, Alicante 03203
    Spain

    Site Not Available

  • Merida, Badajoz 06800
    Spain

    Site Not Available

  • Sabadell, Barcelona 08208
    Spain

    Site Not Available

  • Sant Joan Despi, Barcelona 08970
    Spain

    Site Not Available

  • Terrassa, Barcelona 08221
    Spain

    Site Not Available

  • Jerez de La Frontera, Cadiz 11407
    Spain

    Site Not Available

  • Torrelavega, Cantabria 39300
    Spain

    Site Not Available

  • San Sebastian, Guipuzcoa 20080
    Spain

    Site Not Available

  • Palma de Mallorca, Islas Baleares 07198
    Spain

    Site Not Available

  • La Coruna, La Coruña 15006
    Spain

    Site Not Available

  • Santiago De Compostela, La Coruña 15706
    Spain

    Site Not Available

  • Las Palmas de Gran Canaria, Las Palmas 35016
    Spain

    Site Not Available

  • Fuenlabrada, Madrid 28942
    Spain

    Site Not Available

  • Cartagena, Murcia 30203
    Spain

    Site Not Available

  • El Palmar, Murcia 30120
    Spain

    Site Not Available

  • empty

    Ourense, Orense 32005
    Spain

    Site Not Available

  • Valenica, Valencia 46009
    Spain

    Site Not Available

  • Bilbao, Vizcaya 48013
    Spain

    Site Not Available

  • Alicante, 03010
    Spain

    Site Not Available

  • Barcelona, 08036
    Spain

    Site Not Available

  • Burgos, 06006
    Spain

    Site Not Available

  • Cordoba, 14004
    Spain

    Site Not Available

  • Granada, 18014
    Spain

    Site Not Available

  • Guadalajara, 19002
    Spain

    Site Not Available

  • Madrid, 28905
    Spain

    Site Not Available

  • Malaga, 29009
    Spain

    Site Not Available

  • Salamanca, 37007
    Spain

    Site Not Available

  • Sevilla, 41013
    Spain

    Site Not Available

  • Tarragona, 43700
    Spain

    Site Not Available

  • Tenerife, 38010
    Spain

    Site Not Available

  • Toledo, 45004
    Spain

    Site Not Available

  • Valencia, 46010
    Spain

    Site Not Available

  • Zaragoza, 50009
    Spain

    Site Not Available

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